Identity Management Technologies in Clinical Trials
Track
:
Track 07: Processes and Technologies for Clinical Research
Program Code:
334
Date:
Wednesday, June 27, 2012
Time:
10:00 AM to 11:30 AM
EST
CHAIR
:
Jay Smith, Medidata Solutions Worldwide, United States
Jay Smith has been working with life sciences companies for over 15 years. He has led successful projects in areas such as submission publishing, submission review, electronic document management, software validation, and clinical portal products.
Ravi Rajaram has been in the IT industry for over 25 years out of which 14 years is in the clinical trials domain. At Westat, he has managed several IT projects including a web based Patient registration system, a document image management system, CDISC ODM based clinical data transfer system.
Jay Smith, Medidata Solutions Worldwide, United States
Jay Smith has been working with life sciences companies for over 15 years. He has led successful projects in areas such as submission publishing, submission review, electronic document management, software validation, and clinical portal products.
Kevin is an IT professional with 25 years of experience providing software analysis, development, and architecture services to a wide range of industries. At Mayo Clinic, he has implemented solutions supporting Clinical and Research Laboratory Informatics and Clinical Trials Management Systems.
Description
This session will provide an overview of several new identity management technologies, standards, and practices, as used in software developed for the clinical market. Best practices for each new method or technology will be described, as well as how each might be used in software or clinical development to improve efficiencies and raise quality.
Learning Objectives: Describe how federated authentication may be used to simplify user access to systems that require cooperation among multiple business entities Discuss details and impacts will be provided about EDC, IVRS, and CTMS systems, and regulations such as ER/ES (including 21 CFR Part 11) and GxP.